FDA Grants Go-Ahead for Low-Risk TAVR Study
The US FDA has given a green light to the launch of the first large, randomized trial of transcatheter aortic valve replacement in low-risk patients, the trial sponsor announced today. That announcement is being seen by some as a broad hint that the as-yet undisclosed results from the intermediate-risk TAVR trial with this same device are likely positive.
PARTNER III, using the Sapien 3 valve (Edwards Lifesciences), will enroll approximately 1,300 elderly patients identified by a heart team as being at low risk for mortality were they to undergo surgical valve replacement (STS score < 4). The patients, aged at least 65 years and having severe, symptomatic aortic stenosis, will be randomized at up to 50 sites to either TAVR or surgery. Sites are expected to start enrolling patients this spring.
The next-generation Sapien 3 transcatheter valve received FDA approval last year for use in high-risk or inoperable patients. Patients at intermediate risk are currently the focus of the PARTNER IIA study, results of which will be released at the upcoming American College of Cardiology meeting in April.
Reading the tea leaves, market analyst Larry Biegelsen writes in an equity research report that he sees today’s news as a sign of what PARTNER IIA will show in terms of safety and efficacy in intermediate-risk patients.
“The approval to begin a low-risk trial suggests that the FDA is comfortable with the intermediate-risk data,” the report reads. “Provided the data is positive, the company expects to receive an intermediate risk indication in late 2016, although we think approval could come sooner.”
Early results from Europe and Canada assessing Sapien 3 in intermediate-risk patients showed mortality rates to be as low as 1% at 30 days—roughly equivalent to what is seen with surgical AV replacement
Importantly, the PARTNER III trial will also try to provide clarity on leaflet mobility and thrombosis, which emerged unexpectedly as an issue issues with both transcatheter and surgical valves in patients in who underwent 4-D CT imaging. The new trial will include a 400-patient substudy studying these concerns using “advanced imaging,” a press release from the sponsor notes.
Edwards Lifesciences. Edwards receives FDA approval for expanded indication study of Sapien 3 valve. www.prnewswire.com/news-releases/edwards-receives-fda-approval-for-expanded-indication-study-of-sapien-3-valve-300205013.html. Published: January 15, 2016. Accessed: January 15, 2016.
- Two Trials to Assess TAVR in Moderate-Risk Patients
- Reduced Leaflet Motion in Bioprosthetic Aortic Valves Not Uncommon But Remedied by Anticoagulation
- Sapien 3 Experience in Europe, Canada Shows Low Mortality, Paravalvular Leak at 30 Days